JP6522815B2 - Container, holding device, holding system, and injection aid - Google Patents

Description

  The present invention provides a container for a medicament according to the preamble of claim 1, a container holding device according to the preamble of claim 12, a container holding system according to the preamble of claim 21, and an injection according to the preamble of claim 24. It relates to the aids.

  Pharmaceutical containers, holding devices and holding systems for such containers, and injection aids are known. The holding device can, for example, be formed as a delivery system for a drug container holding system or be included in the injection aid. The container comprises a substrate, preferably configured as a syringe, carpule, vial, or preferably also as a dual chamber system. Usually, containers of such pharmaceutical industry are delivered already washed and / or sterilized, for example for filling with pharmaceuticals such as pharmaceuticals. To that end, it is preferred that a plurality of containers be combined in one holding system. Because the containers are arranged somewhat loosely in the transport system, relative movement can occur during transport, on the one hand between the containers and the transport system and on the other hand between the individual containers. This may cause appearance defects in the container. If the container is configured as a dual chamber system, the container must be inverted to fill both chambers. Because the containers are loosely arranged in the transport system, the containers must be removed from the transport system for inversion and sorted into a specially provided magazine for this purpose. This not only implies an additional work step, but can also lead to container appearance defects when gripping the container for re-sorting. Containers designed as carpule are often used in combination with injection aids, such as so-called automatic injection devices or pens. The injection aid comprises a housing front for receiving the carpule and a mechanical part having an activation and actuation mechanism. Without this housing front, the carpule can not be connected to the mechanical parts. Thus, in generally known containers, the container is connected in an appropriate manner, for example with the delivery system or the injection aid, generally with the mechanical parts of the holding device, so as to ensure that the container is held firmly to these It has the disadvantage of not being able to

  It is therefore an object of the present invention to provide a container and a holding device which do not have the above disadvantages.

  This task is solved by a pharmaceutical container provided with the features of claim 1. The container is characterized in that it comprises at least one holding means co-operable with corresponding holding means of the container holding device in order to hold the substrate firmly in the holding device. Since the holding means is provided to transfer the holding force to the base relative to the base, the container is finally held securely in the holding device. Thereby, the containers are connected, for example, to the carrier system of the holding system in such a way that undesired relative movements can not occur between the containers and the carrier system on the one hand and between the variously arranged containers in the carrier system on the other hand. Can. Moreover, the containers can be handled in conjunction with the delivery system. If multiple containers are arranged in the delivery system, it is only necessary to invert the delivery system for gripping, transport and, in particular, for filling the dual chamber system, it is not necessary to separate the individual containers from the delivery system. Due to the provision of holding means, such a container, for example formed as a carpule, can also be connected with the mechanical parts of the injection aid without the need for a housing front for receiving the container.

  In a preferred container, the holding means comprises at least one projection and / or at least one receiving part. It is preferable that the protrusion and / or the receiving part be provided on the outer peripheral surface of the base. The projection and / or the receiving part may preferably cooperate with at least one corresponding projection and / or at least one corresponding receiving part such that a fitting connection of the container and the holding device is formed. it can.

  For example, in a preferred container, the holding means are co-operable with corresponding holding means in a bayonet closure manner. That is, the retaining means may for example comprise notches extending essentially perpendicularly to one another, for example by means of which the projections of the corresponding retaining means adapted to fit in the notches usually engage the bayonet closure. A plug-in rotary connection is formed as provided by Of course, it is likewise possible for the holding means of the container to be provided with matching projections, which engage in the notches of the corresponding holding means, which extend essentially perpendicularly to one another.

  In a preferred container, the holding means is provided at the proximal end of the substrate. Where the container is configured as a syringe, carpule, or dual chamber system, the container comprises a proximal end and a distal end. In that case, the proximal end is particularly suitable for providing the holding means. It is particularly preferred that the holding means be provided at a distance from the proximal end of the substrate.

  A preferred container also comprises a connection element. The connecting element is configured to receive the tool in a fitted state. The tool has the function of locking or unlocking the container relative to the holding device by causing relative rotation between the holding device and the container. To that end, the connection element is designed to allow torque transfer from the tool to the base of the container, so that the holding means and the corresponding holding means can be connected.

  Finally, the container is preferably configured as a syringe, carpule, vial, or preferably a dual chamber system.

  Further preferred embodiments are given in the dependent claims.

  The problem is also solved by the holding device with the features of claim 12. The holding device comprises at least one receiving part for the container, the receiving part co-operating with at least one corresponding holding means of the container in order to securely hold the substrate of the pharmaceutical container on the holding device. It is characterized in that it comprises at least one holding means which is operatively formed. The holding force can thus be transmitted from the holding device to the substrate via the corresponding holding means, so that in particular the substrate can be handled in conjunction with the holding device.

  In a preferred holding device, the holding means are configured such that, as viewed axially, radially and circumferentially, accidental relative movement between the container fitted in the receiving part and the holding device is prevented. Thus, the container is arranged in the receiving part of the holding device in a reliable and stable manner for all possible degrees of freedom. Since unexpected relative movement can not occur, appearance defects are surely prevented. Also, it is not possible for the container to drop out of the holding device when reversing the holding device.

  In a preferred holding device, the holding means are co-operable with corresponding holding means of the substrate of the container according to any of the preceding claims. This means that the holding means are preferably formed like the holding means of the container according to any one of the claims 1 to 10, or are formed complementary to this holding means. means. That is, for example, if the holding means of the container comprises a projection, it is preferred that the holding means of the holding device comprises a corresponding receiving part, and vice versa.

  The preferred holding device is configured as a delivery system for the drug container holding system. The transport system is preferably provided with two or more receiving parts for two or more containers. In this case, the relative movement between the containers is reliably prevented by the holding means provided in the receiving portion. The integral handling of the delivery system with the container provides a logistical advantage. That is, there is no need to hold individual containers. If the dual chamber system is inserted into the delivery system, the delivery system can be easily inverted to fill both chambers of the dual chamber system, as the dual chamber system can not drop out of the delivery system. Therefore, it is not necessary to use a separate magazine.

  And finally, the preferred holding device is formed as a mechanical part of the injection aid. In this case, the mechanical part of the injection aid includes the receiving portion including the holding means for reliably holding the container, so that the housing front of the injection aid that is originally required can be omitted. This generally allows the injection aid with the holding device to be manufactured cheaper and with lower logistics costs, since the number of parts involved is reduced.

  Further advantageous configurations are indicated in the dependent claims.

  It is also an object of the present invention to provide a holding system which does not have the disadvantages described.

  This task is solved by a holding system comprising the features of claim 21. The holding system is characterized in that it comprises a transport system configured as a holding device according to any of claims 11-18. By ensuring that the containers can be placed in the delivery system, the above-mentioned drawbacks are avoided in the manner already described.

  Further advantageous configurations are indicated in the dependent claims.

  Finally, it is also an object of the present invention to provide an injection aid which does not have the above-mentioned drawbacks.

  This problem is solved by the injection aid provided with the features of claim 24.

  The injection aid is characterized in that it comprises a mechanical part configured as a holding device according to any of the claims 12-20. Furthermore, the injection aid is characterized in that it comprises the container according to any one of claims 1-11. The holding device and the container can be connected to one another via corresponding holding means, so that the housing front can be dispensed with. Thereby, the injection aid can be manufactured at lower material costs and more easily in the logistics, and thus generally cheaper. Furthermore, handling is easier because only two elements need to be connected to one another rather than three.

  Hereinafter, the present invention will be described in detail using the drawings.

FIG. 1 is a diagram of an example of a pharmaceutical container. FIG. 6 shows an embodiment of a holding system and a holding device configured as a transport system. 3 is a cross-sectional view of the holding system and holding device according to FIG. FIG. 3A is a cross-sectional view of a holding system having a modified embodiment of the container. FIG. 3 is a view of the holding system according to FIG. 2 having a plurality of containers arranged in the receiving part of the conveying system formed as a holding device. FIG. 7 is an exploded view of an embodiment of the injection aid with the holding device and the container formed as a mechanical part of the injection aid. FIG. 6 shows the injection aid according to FIG. 5 in the assembled state; FIG. 6 is a cross-sectional detail view of the injection aid according to FIG. 5; FIG. 7 is a cross-sectional view of the injection aid according to FIG. FIG. 7 is an exploded view of the container, the holding device formed as a finger rest, the piston rod and the closure. FIG. 10 is a view of the element according to FIG. 9 in the assembled state; FIG. 1 is a schematic view of the filling of a container formed as a dual chamber system using a holding system comprising a delivery system formed as a holding device. FIG. 1 is a schematic view of the filling of a container formed as a dual chamber system using a holding system comprising a delivery system formed as a holding device. FIG. 1 is a schematic view of the filling of a container formed as a dual chamber system using a holding system comprising a delivery system formed as a holding device.

  FIG. 1 shows an embodiment of a pharmaceutical container 1. The container 1 is here formed as a carpule, but the container 1 can be formed as a single or dual chamber carpule. Preferably, the container is formed as a dual chamber carpule. In another embodiment not shown, the container is preferably formed as a syringe, in particular a single or dual chamber syringe, or a vial.

  The container 1 comprises a substrate 3 which is preferably formed cylindrically.

  When the container 1 is formed as a syringe or as a carpule as shown in FIG. 1, the container comprises a proximal end 5 and a distal end 7. The base 3 is provided with an outer peripheral surface 9.

  At least one holding means 11 is preferably provided on the substrate 3. The holding means are co-operable with corresponding holding means of the holding device in order to hold the substrate securely in the container holding device. This means that a holding force can be transmitted to the base 3 via the holding means 11 in order to hold the base 3. For this purpose it is not necessary for the holding means 11 to be arranged directly on the substrate or to be formed integrally with the substrate. In short, the holding means are provided such that the holding force is transmitted to the base 3.

  However, in the preferred embodiment shown, the holding means 11 is provided directly on the substrate 3. The holding means is preferably formed integrally with the substrate.

  The substrate 3 can preferably comprise glass or plastic. When the substrate 3 contains a plastic, in particular, appearance defects are concerned. If the substrate 3 comprises glass or plastic, it is preferred that the holding means 11 be formed directly on the substrate 3.

  The holding means 11 preferably comprises at least one projection and / or at least one receiving part. Thereby, in order to hold the container 1 in the holding device, the corresponding projections and / or receiving portions of the holding means of the container 1 on the one hand and the container holding device on the other hand are preferably fitted into one another. be able to. Preferably, the projecting portion or the receiving portion is provided on the outer circumferential surface 9.

  The holding means 11 preferably comprises at least two protrusions and / or receiving parts, preferably provided equidistantly on one another, preferably on the circumference of the outer circumferential surface 9.

  It is also possible that the container 1 comprises at least one axial protrusion and / or at least one axial receiver.

  In that context, the axial direction here refers to the longitudinal extension of the container 1. The radial direction is the direction perpendicular to the longitudinal axis of the container 1. The circumferential direction refers to a direction extending around the longitudinal axis of the container 1.

  In another preferred embodiment, the holding means 11 comprises at least one radial protrusion and / or at least one radial receiver. It is preferable that these be similarly disposed on the outer peripheral surface 9.

  In the illustrated embodiment, two radial projections 13, 13 'are provided which face each other as viewed in the radial direction. In other embodiments not shown, two corresponding radial receivers may be provided. It is also possible to provide at least one radial projection and at least one radial reception, or to combine several projections and receptions. In yet another embodiment, the angular pitch between the protrusions and / or the receiving portions may be non-uniform. In that case, these elements do not face each other.

  In the illustrated embodiment, the holding means 11 is provided at the proximal end 5 of the base 3.

  The protrusions 13 and 13 'are preferably formed identically. Therefore, in the following, only the protrusion 13 will be described in detail on the premise that the protrusions 13 'of the illustrated embodiment are formed identically. Of course, in other embodiments it is also possible to provide different projections 13, 13 '.

  The projection 13 comprises at least one radial overhang on the outer circumferential surface 15, here two radial overhangs 17, 17 '. In another embodiment, it is also possible that the projection 13 comprises at least one recess in the outer circumferential surface 15. In still another embodiment, if the holding means 11 comprises a receiving part, this receiving part may also comprise at least one radial overhang and / or at least one radial recess on its outer circumferential surface is there.

  The radial overhangs 17, 17 'or the corresponding radial recesses are preferably provided to increase the friction of the holding means 11 against the corresponding surface of the holding means of the holding device. However, in order to provide a so-called lock of the container 1 in the holding device, the overhangs 17, 17 ′ or the corresponding recesses cooperate with the recesses of the corresponding holding means or the corresponding overhangs. Is also possible. Insofar, the overhangs 17, 17 'or the corresponding overhangs of the corresponding holding means can also be referred to as locking elements.

  The projection 13 comprises at least one, here just one, axial projection 19. Thereby, the recess or the groove 21 is formed between the axially extending portion 19 and the outer peripheral surface 9 when viewed from the radial direction. In another embodiment, at least one axial recess, preferably a groove, may be provided in the projection 13 instead of or in addition to the axial overhang 19. In still another embodiment not shown, if the holding means 11 comprises at least one receiving part, this receiving part comprises at least one axial overhang and / or at least one axial recess, preferably a groove. Can.

  In the illustrated embodiment, the protrusion 13 is formed in a hook-like shape in a cross-sectional view not shown. This is due to the fact that the projection comprises an axial overhang 19 on one side and an axial recess 21 on the other. A mating connection is formed by the engagement of the corresponding holding means on the rear side of the axially extending part 19.

  The holding means 11 are preferably formed cooperably with the corresponding holding means in a bayonet closure manner. Bayonet closures usually include a plug-in rotation mechanism. In this mechanism, at least one projection of one part is first inserted longitudinally into a first receiving part provided in the other part, wherein the second receiving part is the first receiving part Essentially perpendicular to, but offset forward as viewed from the insertion direction of the projection, adjacent. First, if the protrusion advances a fixed distance along the first receiving part in the insertion operation, the rotating part can be used to subsequently turn the protrusion into the second receiving part. As the second receiver extends essentially perpendicularly to the first receiver, both parts can not be separated by pure translational relative movement. Typically, the bayonet closure is biased as viewed in the longitudinal direction so that the projection is pushed into the receiver where there is some static friction.

  The second receiving portion may be provided at an angle to the first receiving portion, in which case the second receiving portion includes a surface which is inclined as viewed in the direction opposite to the insertion direction. When the closure is biased as viewed in the longitudinal direction, a predetermined force must first be applied to insert the projection into the second receiver. And the urging | biasing force which acts on the locking position of a protrusion part is smaller than this force. In order to lock both parts relative to one another, a correspondingly greater force must be applied again. Therefore, the projection is placed at the so-called minimum potential lock position.

  Here, in the following, the concept of the locking position generally refers to the position on the holding device of the container 1 in which the container 1 is securely and firmly arranged in the holding device. This concept does not mean that the presence of a lock between corresponding holding elements is mandatory.

  Preferably, the at least one projection and / or the at least one receiving part of the holding means 11 comprises at least one inclined surface. It may be formed as a beveled surface of the bayonet closure as described earlier. However, at least one inclined surface can also preferably be formed as an insertion inclined surface for securing the holding means to the corresponding holding means of the holding device. Such an insertion ramp has, for example, the function of moving the resiliently mounted locking element when the holding means 11 is inserted. Thereby, when the holding means 11 is fully inserted into the corresponding holding means, the resilient locking element is locked in the relief groove arranged in the area of the insertion ramp. The container 1 is then securely locked in the holding device.

  However, preferably, when connecting the corresponding holding means, an insertion ramp may be provided in order to provide a progressive pressing force or an increase in the friction lock. In particular, it is also possible ultimately to form a self-lock between them, in order to ensure that the corresponding holding means are held relative to one another.

  Overall, the at least one projection and / or the at least one receiving part of the holding means 11 comprises at least one inclined surface, which secures the holding means to the corresponding holding means of the holding device Preferably, it is provided as an insertion ramp for

  FIG. 2 shows an example of a holding system 23 for medicament containers having a holding device 27 configured as a delivery system 25. The same components and components having similar functions are denoted by the same reference numerals, and the above description is referred to for these components. The container 1 is disposed at the receiving portion 29 of the holding device 27.

  The delivery system 25 configured as a retention device 27 shown in FIG. 2 is preferably used in conjunction with a retention system 23 further including tab elements, not shown, on which the delivery system 25 can be arranged. Such a holding system used for the transport, in particular the delivery and handling, of a given number of containers 1 is also commonly referred to as a nested tab structure. A so-called tab is a tab element into which the carrier system 27 formed as a nest can be inserted. The tab is preferably closed with a film. In this way, in particular, a predetermined number of containers 1 can be transported in a pre-sterilized state and kept sterile, so that containers 1 in the tub are filled without the need to sterilize containers 1 anew Can be carried into a sterile room for The nesting or delivery system 25 allows the containers 1 to be handled without having to hold the containers 1 individually.

  The dimensions of the transport system 25 and the tab elements not shown are preferably in accordance with standard packaging formats. This allows the holding system 23 to be used in a standardized filling line. Because known or existing machine and process technology can be used, it is only necessary to adapt the existing installation parts or known processes to nothing or only in order to use the holding system 23.

  The holding device 25 shown in FIG. 2 comprises a plurality of receiving parts 29 for the container 1 which are preferably formed identical. Therefore, in the following, only the receiving part 29 or the receiving part 29 'arranged next to it will be mentioned. Of course, it is also possible to provide the receiving device 27 with different receiving parts.

  The receiving part 29, 29 ′ comprises holding means 11 ′ configured to cooperate with the corresponding holding means 11 of the container 1 in order to hold the substrate 3 securely in the holding device 27.

  The holding device 27 can include at least one receiving portion having a diameter slightly smaller than the outer diameter of the base 3. Then, when at least one of the holding device 27 or the base 3 in the area of the receiving portion 29 is sufficiently elastic, the two elements can be connected by inserting the container 1 into the receiving portion 29. Thereby, they are frictionally locked to each other. However, in this case, appearance defects may occur particularly in the region of the outer peripheral surface 9.

  Thus, the embodiment of the holding device 27 in which a fit is formed between the corresponding holding means is preferred.

  The holding device 27 can in that case be provided with an elastic projection or a so-called elastic annular groove, which is preferably provided at the proximal end 5 of the container 1 in a known manner, into which the flange of the container 1 is fitted. .

  Nevertheless, the holding means 11 preferably comprises at least two radial projections 13, 13 ′.

  The holding means 11 ′ of the holding device 27 is configured to prevent an unexpected relative movement between the container 1 fitted in the receiving portion 29, 29 ′ and the holding device 27 when viewed from the axial, radial and circumferential directions. Preferably, it is formed in That is, the container 1 is held by the holding device 27 so that it can not move unexpectedly in any of these degrees of freedom. Thus, particularly stable support is provided. In particular, it is not possible for the container 1 to rotate or drop off unexpectedly with respect to the holding device 27. Similarly, the container 1 does not come into contact with the container 1 disposed in the adjacent receiving part. Thus, appearance defects are prevented.

  The holding means 11 ′ are preferably configured to cooperate with the corresponding holding means 11 of the container 1. This means that the features described with respect to the holding means 11 of the container 1 also apply to the holding means 11 'of the holding device 27. In particular, the holding means 11 ′ is preferably formed complementary to the holding means 11. In other words, the holding means 11 ′ may comprise matching protrusions, receiving parts, overhangs and / or recesses, which are formed complementary to the matching elements of the holding means 11. Therefore, the general description of the holding means 11 'will be omitted and in this regard the description of the holding means 11 will be referred to. However, the illustrated embodiment of the holding device 27 and the holding means 11 'will be specifically described below.

  The holding means 11 'comprises at least one protrusion and / or at least one receiving part, preferably at least one hook-like protrusion, here in particular two hook-like protrusions 31, 31'. The holding device 27 further comprises an opening 33 in the area of the receiving part 29 '. Via this opening 33 it is possible to reach the chamber of the container 1 arranged in the receiving part 29 ′. Particularly preferably, it is possible to fill the chamber through the opening 33. Particularly preferably, the stopper may be inserted through the opening 33 of the container 1. The stopper may, for example, be the central stopper of a dual chamber system or the end stopper of a syringe, a carpule, or a dual chamber system. For this purpose, the diameter of the opening 33 must be at least just as large or preferably slightly larger than the inner diameter of the area of the chamber to be filled of the container 1 or the area in which the stopper is inserted. However, the opening 33 is preferably dimensioned in terms of its diameter so that the container 1 can be supported on the holding device 27 by the area of the wall of the base 3. Therefore, the diameter of the opening 33 is preferably smaller than the outer diameter of the base 3 in the region where the base 3 abuts on the holding device 27.

  In the illustrated embodiment, the hook-shaped protrusions 31 and 31 ′ are disposed opposite to each other as viewed in the radial direction of the opening 33. Since they are preferably identical, only the protrusions 31 will be described in more detail below.

  The projection 31 comprises an axial overhang 35 and a matching axial recess 37. Thereby, the hook shape of the protrusion 31 is basically formed. In the locked position of the container 1, the projection 13 engages with the recess 37 by means of the overhang 19, while at the same time the overhang 35 engages with the recess 21. In this manner, the fitting is formed, and the container 1 is held by the holding device 27 in the axial and radial directions as well.

  The radial overhangs 17, 17 ′ provided on the projections 13 are provided in the embodiment shown to increase the friction between the projections 13 and the projections 31, whereby in particular viewed from the circumferential direction, It is ensured that the container 1 is reliably stationary with respect to the holding device 27.

  The projection 13 'cooperates with the projection 31' in a corresponding manner.

  In the illustrated embodiment, the container 1 can be pivoted in its locked position. To that end, the container 1 is first arranged in the receiving part 29 offset approximately 90 ° with respect to its illustrated position and then pivoted approximately 90 °. As a result, the projections 13, 13 ′ and 31, 31 ′ engage one another so that the container 1 is finally placed in its locking position. At that time, the protrusions 13 and 13 ′ are supported by the mounting surface 39.

  FIG. 3 is a cross-sectional view of the holding system according to FIG. The same components and components having similar functions are denoted by the same reference numerals, and the above description is referred to for these components. FIG. 3 shows that the protrusion 13 engages with the protrusion 31 so that the protrusion 19 engages with the recess 37 while the protrusion 35 engages with the recess 21. . The same applies to the protrusions 13 'and 31'.

  The protrusions 31 and 31 ′ are disposed to face each other along the periphery of the opening 33.

  In the embodiment shown in FIG. 3, the container 1 is formed as a dual chamber system. The container comprises a distal chamber 41 and a proximal chamber 43 separated from one another by a central stopper 45. To activate the dual chamber system, the central stopper 45 can be moved to the area of the bypass 47 in a known manner to establish a fluid connection between the distal chamber 41 and the proximal chamber 43.

  The central stop 45 can be introduced into the interior of the basic body 3 through the opening 33, together with the holding device 27 or the transport system 25.

  The tip 7 of the container 1 is closed by the closure 49. If the drug loaded in the tip chamber 41 is not lyophilized, the container 1 can be completely filled via the opening 33. In that case, the container is first closed by the closure 49. Then, the tip chamber 41 is filled. Thereafter, the central stopper is inserted. Subsequently, the proximal chamber 43 is filled. Finally, the end stopper 51 is inserted. The end stop preferably comprises connection means, here a thread 53, for connection with the piston rod.

  However, in the case of lyophilizing the drug loaded in the tip chamber 41, another procedure of the filling step is required. In this case, the container 1 has to be reversed. In the illustrated embodiment this is possible by inverting the holding device 27 or the conveying system 25. At this time, since the container 1 is securely disposed in the transport system, the container does not accidentally separate or drop off from the transport system 25. In the following, the filling of the corresponding dual chamber system will be described in more detail.

  In the illustrated embodiment, the container 1 is provided at its proximal end 5 with at least one holding means 11. In other embodiments, it is also possible to arrange at least one holding means 11 in another area of the container 1. For example, the holding means 11 may be arranged somewhat towards the center of the container 1. In that case, correspondingly, the holding device 27 is arranged in a corresponding central area of the container 3. It is also possible to provide at least one holding means 11 at the tip 7 of the container 1.

  In the embodiment shown, it is shown that the container 1 is locked with the holding device 27 essentially by means of a rotating or pivoting movement. At that time, when the container 1 is gripped by a tool for applying a torque necessary for locking by friction locking, the container 1 may have an appearance defect. Accordingly, the container 1 preferably includes a connecting element that is formed to acceptably receive the tool in order to transfer torque from the tool to the substrate. Preferably, the inner side wall of the base 3 may be formed in the area of the proximal end 5 so that the tool can be engaged. For example, a rectangular receiving unit may be configured here. Other shapes are also conceivable, for example hexagonal receiving parts. Also, a polygon or similar shape is possible which is in contact with the outer circumferential surface 9 for gripping the corresponding tool. At least one ridge and / or recess cooperable with the tool to apply the necessary torque to the lock, at the front end of the container 1, ie preferably at the proximal end 5 or the distal end 7 It is also possible to provide in the area.

  Preferably, a plug-in connection may be formed, in which the container 1 is inserted longitudinally in the receptacle of the adapted holding device 27.

  Preferably, at least one of the holding means 11, 11 'comprises an inclined surface. In the illustrated embodiment, for example, the bottom of the recess 37 or the bottom of the recess 21 can be formed as an inclined surface. In this case, the inclined surface is preferably inclined as viewed from the circumferential direction. In response to this, the recess having the inclined surface changes in depth as viewed from the circumferential direction. Preferably, the deepest area of the recess is engaged with the overhang that engages it. On further movement in the direction of the locking position, the depth of the recess decreases until a matching ledge is arranged at the bottom of the recess. At least one of the two holding means 11, 11 'connected to one another is resilient enough to allow further movement in the direction of the locking position, wherein at least one of the two elements is at least slightly It is preferable to be transformed into This creates a biasing force that counteracts the unintended separation of the connection. The at least one inclined surface may be inclined at an appropriate angle to cause self-locking in this area.

  An inclined surface corresponding to this may be provided also on the overhanging portion 35 or the overhanging portion 19. It is also possible to form inclined surfaces on the holding means which are formed differently from the illustrated embodiment.

  Preferably, at least one resiliently attachable locking element can be provided, for example resiliently attached pins or detents or snaps. This locking element is preferably first of all deflected backward or backwards by means of the inclined surface when the corresponding holding means are engaged, and finally of the inclined surface acting as an insertion inclined surface, viewed from the insertion direction. It locks in the lock position in the relief groove arranged on the rear side. Depending on the method of connection, the insertion direction may coincide with the longitudinal direction (plug-in connection) or the circumferential direction of the container 1 (rotational or pivoting connection).

  FIG. 3A is an enlarged cross-sectional view of the holding system according to FIG. The same components and components having similar functions are denoted by the same reference numerals, and the above description is referred to for these components.

  FIG. 3A shows a modified embodiment of the container 1 in which the end stopper 51 is fitted into the proximal end 5 of the container 1. This container 1 differs from the container shown in FIG. 3 in that the holding means 11 are not directly on the proximal end 5 of the container but at a distance from the proximal end. When the holding means 11 of the container 1 is connected to the holding means 11 ′ of the receiving part 29 of the holding device 27, the proximal end portion A of the base 3 of the container 1 projects from the transport system 25. FIG. 3A shows that the substrate 3 overhangs the transport system 25 and is placed by its holding means 11 on the mounting surface 39 of the transport system 25. A portion A protrudes from the transport system 25 on the opposite surface of the mounting surface 39. The part A is preferably formed integrally with the base 3 of the container 1 as shown in FIG. 3A.

  It can be seen from FIG. 3A that preferably part A can be covered with an insertion aid E, the inner diameter of which corresponds to the inner diameter of the base 3 of the container 1. The insertion aid E comprises a fixing flange that surrounds the part A from the outside in order to hold the insertion aid E firmly in the part A.

  In the embodiment shown in FIG. 3A, a connecting element, here preferably formed as an O-ring R, is provided between the outer surface of the part A and the inner surface of the fixing flange B.

  In the embodiment shown in FIG. 3A, the insertion assisting portion E is formed in a cylindrical shape. Similarly, the fixing flange B is formed in a cylindrical or ring shape. However, it is also fully conceivable that this fixing flange B is not formed as a closed ring but comprises a certain number of individual fixing arms via which the insertion aid E can be held in the part A of the base body 3 .

  The ring-like configuration of the fixing flange B is particularly preferred in the context of the O-ring R. In other words, the insertion assisting portion E can be placed in close contact with the proximal end portion A of the base 3 of the container 1. Then, before inserting a stopper, a stopper insertion apparatus can be attached to the insertion assistance part E so that a vacuum space may be formed in the inside of a container. Therefore, the O-ring R seals the insertion aid E against the part A so that a vacuum space is formed in the container 1 without loss.

  When the stopper is fitted, the insertion assisting portion E also functions as a guiding aid for the stopper fitting device. Thereby, the device can be optimally arranged with respect to the container 1 provided with the stopper.

  After all, it is clear from FIG. 3A that in the alternative embodiment of the container 1 the holding means 11 of the container are placed on the mounting surface 39 of the transport system 25 as in the embodiment of the container 1 described at the beginning. However, in the embodiment according to FIG. 3A, the base 3 of the container 1 projects through the transport system 25 so that the part A of the base 3 projects from the side facing the mounting surface 39 of the transport system 25. As a result, the portion A can be covered with the insertion assisting portion E that facilitates the insertion of one or more stoppers into the interior of the container 1. As a result, the so-called stopper fit is basically improved and at the same time the filling process of the container 1 is also improved.

  In that case, it is particularly advantageous that the stopper inserted in the insertion aid E can very easily be made the base 3 of the container 1 since the inner surface of the insertion aid E is transferred to the inner surface of the part A of the base 3 of the container 1. It can be led inside.

  Besides, it has been shown that the part A projecting from the delivery system 25 already facilitates the stopper fitting, even if the insertion aid E of the type shown in FIG. 3A is not provided. Thus, the stopper fitting may be attached directly to part A. Nevertheless, this insertion aid E makes the stopper fit particularly easy and at the same time improves the filling process.

  From the description with respect to FIG. 3A, in the end of the insertion aid E turned away from the part A to the insertion aid E which is here formed cylindrical and has a cylindrical internal space, an end directed to the part A It can be readily appreciated that a conical interior space may be provided, having an inner diameter greater than the section. This means that the free end of the insertion aid E has a larger inside diameter than the base 3 and the part A. Therefore, the stopper is very easy particularly when the same inner diameter is provided in the transition area from the internal space of the insertion auxiliary part E to the internal space of the part A so that the insertion auxiliary part E smoothly transitions to the part A. Into the free end of the insertion aid E and then lead into the interior of the base 3.

  The conical interior space of the insertion aid E is indicated by the dashed line K in FIG. 3A. The inclination angle of the line K with respect to the cylindrical inner surface can be adapted to the various stops used with the container 1. As the amount of compression required when inserting the stopper into the container 1 is larger, it is preferable to select a large inclination angle of the conical inner surface. That is, the larger the angle of inclination of the line K with respect to the inner surface of the insertion aid E, here illustrated as cylindrical, the wider the internal space of the insertion aid opens towards the free end.

  From the above, it can be easily seen that the conical inner region of the insertion aid E does not have to extend over the entire length of the insertion aid E from its free end to the end of the part A. It is sufficient if the conical area is formed directly on the free end of the insertion aid E in order to facilitate the insertion of the stopper.

  Furthermore, in order to facilitate the insertion of the stopper, it is also possible to round the edge of the internal space in the area of the free end of the insertion aid E.

  FIG. 4 shows the holding system according to FIG. 2 in which the entire conveying system 25 is shown. The same components and components having similar functions are denoted by the same reference numerals, and the above description is referred to for these components. In the illustrated embodiment, the container 1 is arranged in each of a plurality of receiving parts, here by way of example only the receiving parts 29. It will be appreciated that the illustrated embodiment of the delivery system 25 is a nested tab arrangement of nests which can be delivered and handled in a pre-sterilized condition with a predetermined number of containers 1. It is also shown that in order to fill the container 1 it is only necessary to grip the transport system 25. That is, it is not necessary to hold the individual containers 1 and arrange them in separate devices. The container 1 is firmly held by the transport system 25 so that by simultaneously gripping or handling the containers via the transport system, the entire filling process is made very easy, and in particular in an automated manner. It can be carried out.

  FIG. 5 shows the injection aid 55 in a partially disassembled state. The holding device 27 is here formed as a mechanical part 57 of the injection aid 55. The same components and components having similar functions are denoted by the same reference numerals, and the above description is referred to for these components. The mechanical part 57, which is designed as an auxiliary device 27, comprises a receiving part 29. The receiving part here is basically identical to the holding means 11 'of the holding device 27 of FIGS. However, in the illustrated embodiment, a retaining ring 59 is provided instead of the two protrusions 31 and 31 ', and the retaining ring has an overhang 35 and a recess 37 not shown here, and an opposing element not shown as well. In other words, the corresponding overhang and the corresponding recess are arranged. The ring 59 further comprises an opening 61 on the front side, through which the container 1 can be fitted into the receiving part 29 by the holding means 11. At this time, since the opening 61 has a shape that complements the holding means 11, the container 1 can be fitted only at a position rotated approximately 90 ° around the longitudinal axis with respect to the illustrated lock position.

  Otherwise, the holding means 11, 11 'can be connected in the same way as in the case of the embodiment already described. It is also easily possible to deviate from the illustrated configuration, for example in the context of plug-in connections, in view of the other embodiments described above but not shown. Also, instead of the ring 59, protrusions 31 and 31 'may be provided.

  In the illustrated embodiment, the retaining ring 59 further comprises two radial slots, of which only these inner slots 63 are shown. The projection 13 engages with this slot. A projecting portion 13 '(not shown) engages with the opposite slot (not shown). It is possible to provide walls instead of slots in this area, in which case it is preferable that the friction between the area of the overhang 17, 17 'and the wall is increased. Of course, it is also possible for the wall to have a matching recess, to which the overhangs 17, 17 'are preferably in locking engagement.

  When at least one of the holding means 11, 11 'has a certain degree of elasticity and is connected or locked, a biasing force for holding the container 1 in the holding device 27 particularly securely and stably is It is particularly preferred to select the dimensions of the holding means 11, 11 'so as to be added to this connection. It will be clear that the housing front for receiving the container 1 can be omitted. Thus, the injection aid 55 is particularly simple.

  Known injection aids with a housing front for receiving the container 1 usually comprise at the tip end a connection element for connecting an injection element, for example a cannula, to the injection aid 55.

  In the illustrated embodiment, the closure 49 of the container 1 is preferably provided with a connecting element 65. The connection element is formed here as a thread 67. This screw thread engages with the corresponding thread provided on the injection element. In addition, the closure 49 comprises a sealing element, here configured as a septum 69.

  6 shows the injection aid 55 according to FIG. 5 in the assembled state. The same components and components having similar functions are denoted by the same reference numerals, and the above description is referred to for these components. An injection element 71 is arranged in the region of the closure 49 which is not shown here. The injection element is provided with an internal thread which is not shown, which likewise engages in the external thread 67 of the closure 49 which is not shown. The injection element 71 comprises a holding element 73 with a matching internal thread, and an injection needle 75 held by or disposed on the holding element 73.

  7 is a cross-sectional detail view of the injection aid 55 according to FIG. The same components and components having similar functions are denoted by the same reference numerals, and the above description is referred to for these components. The mechanical part 57 contains the elements necessary for the preparation and execution of the injection with the injection aid 55. If the container 1 is configured as a dual chamber system, the mechanical component 57 also contains the elements necessary for reconstitution of the drug loaded in the tip chamber. In particular, the mechanical part 57 comprises a piston rod, not shown here, which engages with the end stop 51 preferably by means of a thread 53.

  The container 1 and the machine part 57 have to be aligned with one another in order to ensure that the injection is prepared and carried out without problems. This means that the longitudinal axes of the container 1 and the machine part 57 have to coincide.

  Alignment is preferably performed via the opening 61. As shown in FIG. 5, the inner diameter of the opening is not constant, and preferably changes along the circumference of the opening 61. Similarly, the opening preferably has a region whose inner diameter substantially matches the outer diameter of the base 3. The container 1 is centered with respect to the mechanical component 57 by the outer peripheral surface 9 of the base 3 abutting on the inner surface 77 of the opening 61. The inner diameter of the opening 61 is particularly preferably smaller than the outer diameter of the base 3 in a partial region. Since either the base body 3 or the holding element 11 ′ preferably has elasticity in the region of the opening 61, a frictional locking connection provided by the biasing force is formed in the contact area between the outer circumferential surface 9 and the inner surface 77 Be done. The retaining element 11 'is preferably resiliently formed in this area. In general, particularly positive alignment is thus achieved.

  In another embodiment, the alignment takes place via the piston rod of a mechanical part 57 not shown here. The piston rod preferably has an outer diameter which at least in the insertion region of the piston rod coincides with the inner diameter of the base body 3 so that when the piston rod is inserted into the machine part, the base body 3 is aligned with the machine part 57 Be done.

  FIG. 8 is a cross-sectional view of the entire injection aid 55 in the longitudinal direction according to FIG. The same components and components having similar functions are denoted by the same reference numerals, and the above description is referred to for these components. Here, in particular the injection element 71 is shown. The injection element is arranged at the closure 49 by means of the connection element 65. At this time, the female screw 79 of the holding element 73 is screwed into the male screw 67 of the closure 49.

  The injection element 71 comprises, in the illustrated embodiment, an injection needle 75 whose tip has been processed not only at the tip but also at the proximal end. The injection needle pierces the septum 69 with its tip when the injection element 71 is placed on the closure 49. As a result, a fluid path is formed from the tip chamber 41 to the periphery of the substrate 3 via the injection needle 75, so that the drug substance loaded in the tip chamber 41 can be injected finally.

  It is shown that the holding means 11 provided on the container 1 can also cooperate with a holding device different from the embodiments of the holding device described above. For example, an installation part for further processing steps, for example labeling of the container 1, may be provided with equivalent holding devices so that the container 1 can be gripped or held.

  Attachments for handling, activation and / or administration of the medicament loaded into the container 1 or the container 1 may also be formed as or comprise such a holding device.

  FIG. 9 shows a further embodiment of the holding device 27, here formed as a finger rest 81. The same components and components having similar functions are denoted by the same reference numerals, and the above description is referred to for these components. Further shown in FIG. 9 is an exploded view of the container 1 with the closure 49, the sealing element or partition 69 and the piston rod 83. The finger hold portion 81 has a receiving portion 29 having holding means 11 ′ capable of cooperating with the holding means 11 of the container 1 in order to hold the base 3 of the container 1 securely to the holding device 27 or the finger hold portion 81. Is equipped. In that case, it is preferable that holding means 11 and 11 'are formed by the method already demonstrated.

  The finger rest here comprises a ring 85 projecting radially inwards. The inner diameter of the ring is preferably smaller than the inner diameter of the proximal opening of the base 3. Thereby, the ring 85 functions as a retaining element, for example, a so-called backstop, which prevents the end stopper 51 from coming off the base 3.

  The retaining element of such an end stop 51 may be provided on the finger rest 81 in another known manner. It is also possible that the retaining element cooperates with the piston rod 83 such that the retaining element does not stop the removal of the end stop 51 directly, but that the end stop 51 can not return past a predetermined position.

  The closure 49 is formed here as a closure suitable for lyophilisation in a manner known per se, the closure being open relative to the container 1 in such a way that a fluid channel is released around the container 1 in order to enable lyophilisation. It can be placed in one lock position. Furthermore, the closure can also be arranged in a second locking position in which the tip 7 is securely closed.

  FIG. 10 shows the embodiment according to FIG. 9 in the assembled state. The same components and components having similar functions are denoted by the same reference numerals, and the above description is referred to for these components. Here, the finger hold portion 81 is connected to the container 1 via the holding means 11, 11 '. The holding means 11, 11 'are preferably locked to one another.

  Further, the following is shown. The locking connection of the holding means 11, 11 'may possibly be formed such that the connection can not be released again nondestructively. This is especially the case if the resilient locking element initially retracts or reverses, for example by means of the insertion ramp, and subsequently locks onto the relief groove. The holding device 27 is disposed of in conjunction with the container 1 if the holding elements 11, 11 'are locked irremovably. If, on the other hand, the holding elements 11, 11 'are releasably connected to one another, the holding device 27 can be reused, if necessary, also when the container 1 is disposed of after use.

  FIG. 11 is a schematic view of the method of filling the container 1 formed as a dual chamber system, when the pharmaceutical product is lyophilized in the tip chamber 41. The same components and components having similar functions are denoted by the same reference numerals, and the above description is referred to for these components.

  At the left end of FIG. 11 there is shown a holding system 23 comprising a tab element 87 on which a conveying system 25 is arranged. The tab element comprises a receiving part 29 in which the container 1 is arranged. Preferably, the holding system 23 corresponds to a tab-nesting structure, the tab elements 87 as tabs and the conveying system 25 or the holding device 27 as a nest. The tab element 87 is preferably closed with a film element not shown. After the holding system 23 has been carried into the sterile room, the film element is removed and at the same time the tab element 87 is opened. The central stop 45 can then be arranged on the container 1 through the delivery system 25. This is preferably done in parallel for all the containers 1 arranged in the delivery system 25 as well as further processing steps. However, here, the treatment process will be described using one container 1 as an example. However, the central stop 45 may also be fitted after the delivery system 25 has already been removed from the tab element 87.

  Next, inverting the delivery system 25 results in the configuration shown in FIG. 11a). The tip chamber 41 is preferably filled through the tip opening 89 of the container 1.

  As shown in FIG. 11 b), the closure 49 is then placed in the first locking position of the container 1 in a known manner, with the fluid path from the tip chamber 41 to the periphery of the container 1 remaining There is.

  Subsequently, the delivery system 25 is carried with the container 1 into a lyophilizer 91, here schematically illustrated.

  FIG. 11 c) shows the container 1 before lyophilisation. FIG. 11 d) shows the container 1 after lyophilization and after the closure 49 has been placed in its second locking position, the septum 69 or the corresponding sealing element sealingly closing the opening 89. Afterward, the fixing ring 93 may simply be moved to its fixing position where the closure 49 is securely held by the container 1.

  During the whole process, in particular also during lyophilisation, the container 1 remains arranged in the delivery system 25. The delivery system is relatively thin and lightweight and preferably comprises plastic. As a result, the heat capacity of the transport system 25 is reduced, and energy can be saved particularly during cooling, and during subsequent freeze-drying or heating after freeze-drying. In contrast, conventional containers have much higher heat capacity and must be sorted into heavy, heavy metal or steel magazines for handling. The transport system 25 comprising or consisting of plastic can be disposed of after the procedure illustrated here. On the other hand, known metal or steel magazines have to be subjected to complicated cleaning and sterilization or autoclaving. Also in this respect, the transport system 25 can simplify process control. The tab element 87 also preferably comprises or consists of plastic.

  In FIG. 11 e) the delivery system 25 with the container 1 is removed from the lyophilizer 91. The locking ring 93 is now in its locking position, so that the closure 49 is securely and securely in the container 1.

  To fill the proximal chamber 43 as shown in FIG. 11 f), the container 1 has to be inverted. This is done here by simply reversing the delivery system 25. Since the container 1 is securely disposed in the receiving unit 29, the container can not be detached, and the transport system 25 can be used to collect the container 1 and easily invert it.

  Finally, in the step shown in FIG. 11g), the end stop 51 is inserted through the delivery system 25 or the opening 33.

  FIG. 11 h) shows the container 1 now not in engagement with the delivery system 25. The container is preferably further subjected to a final inspection before being put to use. In that case, as already explained, the holding means 11 can be used to engage the container 1 with a further holding device, for example a labeling device or an injection aid.

  Generally, the proposed container 1, the proposed holding device 27, the proposed holding system 23 and the proposed injection aid 55 are formed by means of the holding means 11, 11 ′, in particular reliable and stable It has been shown that it features a good connection. The handling of the plurality of containers 1 is thereby also considerably facilitated. Moreover, appearance defects of the container 1 are reliably prevented. The injection aid 55 can be easily manufactured without expensive physical distribution costs and therefore inexpensively.

Reference Signs List 1 container 3 base 5 base end 11, 11 'holding means 13, 13' protrusion 15 outer circumferential surface 17, 17 'radial extension 19 axial extension 21 axial recess 27 holding device 29, 29' reception Department

Claims (5)

Device for holding a pharmaceutical container comprising a plurality of receiving parts (29, 29 ') for a plurality of containers (1), comprising:
The plurality of receiving parts (29, 29 ′) correspond to at least one of the containers (1) in order to securely hold the base (3) of the container (1) for medicines on the holding device (27). Holding means (11) formed cooperatively with the holding means (11), said holding device (27) for the holding system (23) of the medicament container (1) Formed as a delivery system (25), the holding means (11 ') comprises at least one hook-like projection (31, 31') and / or at least one receiving part,
Said at least one hook-like projection (31, 31 ') and / or said at least one receiving part comprises an axial overhang (35) and a matching axial recess (37);
Said holding means (11 ') are formed cooperably with the corresponding holding means (11) in a bayonet closure manner, as the bayonet closure manner, the corresponding holding means (11) is inserted axially look including an insertion rotation mechanism which is rotated about an axis in the inserted state,
The holding device (27) comprises at least one opening (33), which can reach through the opening (33) the chamber of the container (1) arranged in the receiving part (29, 29 ') A holding device characterized in that 2. The holding device according to claim 1 , wherein in the area of the opening (33), two hook-shaped protrusions (31, 31 ′) are provided facing each other when viewed from the circumferential direction. The device according to claim 1 or 2 , characterized in that the holding device (27) is configured as a nest for placement within a tab element (87), the tab element (87) being configured as a tab. Holding device as described. A holding system for pharmaceutical containers provided with a delivery system (25), comprising:
A holding system, characterized in that the transport system (25) is formed as a holding device (27) according to any one of the preceding claims . A holding system according to claim 4 , characterized in that it comprises a tab element (87) on which the conveying system (25) can be arranged.

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